Diaper Distribution in Low-Income Infants
| Status: | Withdrawn |
|---|---|
| Conditions: | Depression |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/17/2018 |
| Start Date: | March 14, 2018 |
| End Date: | January 2019 |
A Pilot Randomized Controlled Trial of Diaper Distribution in Low-Income Infants
The adverse effects of poverty at the individual, family, and community level on health
outcomes for children are well-established. Material hardship, defined as difficulty meeting
basic needs such as food, housing, and consumer goods, has been shown to have negative
physical and emotional effects on both children and their parents. Diaper need, defined as a
lack of sufficient supply of clean and dry diapers, is an example of a material hardship.
Community-based studies of low-income families have demonstrated that between 30-50% of
caregivers of young children expressed diaper need. Some of these caregivers with diaper need
reported reducing diaper changes, a practice that is associated with diaper dermatitis and
urinary tract infections (UTIs). These community-based studies have also shown that diaper
need is associated with maternal depression and parental stress, even after adjusting for
demographic factors and food insecurity. Diaper need may be a specific modifiable marker of
caregiver stress and depression, beyond its role as an indicator of poverty. In this pilot,
randomized controlled trial of low-income newborns and their caregivers the investigators
will test the feasibility of supplying diapers as an intervention to infants in low-income
families and assess if it can improve both a child's health and their caregiver's overall
health.
outcomes for children are well-established. Material hardship, defined as difficulty meeting
basic needs such as food, housing, and consumer goods, has been shown to have negative
physical and emotional effects on both children and their parents. Diaper need, defined as a
lack of sufficient supply of clean and dry diapers, is an example of a material hardship.
Community-based studies of low-income families have demonstrated that between 30-50% of
caregivers of young children expressed diaper need. Some of these caregivers with diaper need
reported reducing diaper changes, a practice that is associated with diaper dermatitis and
urinary tract infections (UTIs). These community-based studies have also shown that diaper
need is associated with maternal depression and parental stress, even after adjusting for
demographic factors and food insecurity. Diaper need may be a specific modifiable marker of
caregiver stress and depression, beyond its role as an indicator of poverty. In this pilot,
randomized controlled trial of low-income newborns and their caregivers the investigators
will test the feasibility of supplying diapers as an intervention to infants in low-income
families and assess if it can improve both a child's health and their caregiver's overall
health.
Infants born at Boston Medical Center and their caregivers will be recruited at any scheduled
visit at Boston Medical Center's primary care clinic between birth and 2 months of age.
Eligible caregivers will complete a baseline survey and provide consent for the study
investigators to perform a prospective chart review. The infant-caregiver pair will be
randomized to the intervention group or the control group. The intervention group will
receive 600 diapers, distributed in packs of 200 to the families at the conclusion of the 2
month, 4 month, and 6 month old well-child visits. The control group will receive resources
of diaper banks in the greater Boston area.
Surveys:
- Baseline: At the initial visit, the survey will obtain baseline data from the child's
caregiver on prior history of diaper need, current employment and income, government
benefits, and other material hardships. The survey will also include the Protective
Factors Strength Level and Patient Health Questionnaire (PHQ-9), both validated
measures. The survey will take approximately 15-20 minutes to complete. Baseline surveys
will be completed in person.
- Follow-up: At the 2 month, 4 month, 6 month, and 9 month well-child visits (as
applicable based on age of enrollment), all enrolled families will complete a survey
repeating the measures of diaper need, the Protective Factors Strength Level, and PHQ-9.
Additional questions will ask about episodes of diaper rashes and economic impact of
diaper need. Families in the intervention group will be asked about acceptability of the
intervention at the conclusion of the study.
Chart review: After the completion of the 2 month, 4 month, 6 month, and 9 month well-child
visits, study staff will review the medical record for attendance at planned well-child
visits, adherence to the immunization schedule, number of urgent care and ED visits, and
incidence of diaper dermatitis and urinary tract infections requiring treatment. Demographic
information extracted will include sex, race/ethnicity, and confirmation of insurance status.
All survey and chart review data will be de-identified and entered into REDCap with a unique
study identification number.
visit at Boston Medical Center's primary care clinic between birth and 2 months of age.
Eligible caregivers will complete a baseline survey and provide consent for the study
investigators to perform a prospective chart review. The infant-caregiver pair will be
randomized to the intervention group or the control group. The intervention group will
receive 600 diapers, distributed in packs of 200 to the families at the conclusion of the 2
month, 4 month, and 6 month old well-child visits. The control group will receive resources
of diaper banks in the greater Boston area.
Surveys:
- Baseline: At the initial visit, the survey will obtain baseline data from the child's
caregiver on prior history of diaper need, current employment and income, government
benefits, and other material hardships. The survey will also include the Protective
Factors Strength Level and Patient Health Questionnaire (PHQ-9), both validated
measures. The survey will take approximately 15-20 minutes to complete. Baseline surveys
will be completed in person.
- Follow-up: At the 2 month, 4 month, 6 month, and 9 month well-child visits (as
applicable based on age of enrollment), all enrolled families will complete a survey
repeating the measures of diaper need, the Protective Factors Strength Level, and PHQ-9.
Additional questions will ask about episodes of diaper rashes and economic impact of
diaper need. Families in the intervention group will be asked about acceptability of the
intervention at the conclusion of the study.
Chart review: After the completion of the 2 month, 4 month, 6 month, and 9 month well-child
visits, study staff will review the medical record for attendance at planned well-child
visits, adherence to the immunization schedule, number of urgent care and ED visits, and
incidence of diaper dermatitis and urinary tract infections requiring treatment. Demographic
information extracted will include sex, race/ethnicity, and confirmation of insurance status.
All survey and chart review data will be de-identified and entered into REDCap with a unique
study identification number.
Inclusion Criteria:
- Infants born at Boston Medical Center and seen in BMC pediatric primary care clinic at
any outpatient visit between birth and 2 months of age.
- Caregivers of enrolled infants, including parents and legal guardians.
- Plan to obtain pediatric primary care at BMC for nine months.
- Have public insurance or Medicaid as their primary source of health insurance.
Exclusion Criteria:
- Caregivers who are minors (under age 18).
- Infants in the foster care system.
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